Cubist Pharma (CBST) Reports Results from ENTEREG Phase 4 Study in Radical Cystectomy Patients
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Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that a Phase 4 study of ENTEREG® (alvimopan) in patients undergoing radical cystectomy met its primary endpoint of time to achieve recovery of both upper and lower gastrointestinal (GI) function. All secondary endpoints, including length of hospital stay, also achieved statistical significance. Delayed recovery of GI function is one of the most common complications prolonging hospital stay in patients undergoing radical cystectomy. In this study, the adverse event profile was comparable between ENTEREG and placebo. This study was a post-approval commitment with the U.S. FDA.
The Phase 4 investigation was a randomized, double-blind, placebo-controlled study of ENTEREG 12 mg or placebo administered by mouth once preoperatively and twice daily (BID) postoperatively for a maximum of 15 hospital doses in 280 patients undergoing radical cystectomy. Assessments for efficacy were performed over a 10-day observation period and safety evaluated through 30 days after the last dose of study drug.
For the primary endpoint, ENTEREG accelerated upper and lower GI recovery compared to placebo (hazard ratio=1.8, p<0.0001). The median time to achieve GI recovery was 1.2 days earlier in patients receiving ENTEREG compared to placebo. The mean and median postoperative hospital length of stay for patients receiving ENTEREG was 2.6 and 1.0 days shorter, respectively, compared to patients receiving placebo (p=0.005).
The most frequently reported treatment-emergent adverse events in the trial were hypokalemia, anemia and postoperative ileus. The rate of postoperative ileus was higher in the placebo-treated group compared to the ENTEREG-treated group. The incidence of all other treatment-emergent adverse events, including hypokalemia and anemia, was comparable between the two groups. The majority of treatment-emergent adverse events were mild or moderate in severity. The incidence of severe treatment-emergent adverse events was comparable between the two treatment groups. In this study, cardiovascular adverse events were adjudicated by an external independent clinical committee. The incidence of cardiovascular events was 15% percent for placebo-treated patients and 8.4% for ENTEREG-treated patients, which was not statistically different (p=0.09).
The Phase 4 investigation was a randomized, double-blind, placebo-controlled study of ENTEREG 12 mg or placebo administered by mouth once preoperatively and twice daily (BID) postoperatively for a maximum of 15 hospital doses in 280 patients undergoing radical cystectomy. Assessments for efficacy were performed over a 10-day observation period and safety evaluated through 30 days after the last dose of study drug.
For the primary endpoint, ENTEREG accelerated upper and lower GI recovery compared to placebo (hazard ratio=1.8, p<0.0001). The median time to achieve GI recovery was 1.2 days earlier in patients receiving ENTEREG compared to placebo. The mean and median postoperative hospital length of stay for patients receiving ENTEREG was 2.6 and 1.0 days shorter, respectively, compared to patients receiving placebo (p=0.005).
The most frequently reported treatment-emergent adverse events in the trial were hypokalemia, anemia and postoperative ileus. The rate of postoperative ileus was higher in the placebo-treated group compared to the ENTEREG-treated group. The incidence of all other treatment-emergent adverse events, including hypokalemia and anemia, was comparable between the two groups. The majority of treatment-emergent adverse events were mild or moderate in severity. The incidence of severe treatment-emergent adverse events was comparable between the two treatment groups. In this study, cardiovascular adverse events were adjudicated by an external independent clinical committee. The incidence of cardiovascular events was 15% percent for placebo-treated patients and 8.4% for ENTEREG-treated patients, which was not statistically different (p=0.09).
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